Methods of making reinforced soft tissue grafts with suture loop/needle constructs

ABSTRACT

A method of reinforcing a biological construct according to an exemplary aspect of the present disclosure includes, among other things, attaching a suture loop/needle construct to a reinforcement material and stitching the reinforcement material to a biological construct to form a reinforced biological construct. The reinforcement material is attached to the suture loop/needle construct prior to approximating the reinforcement material to the biological construct.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation U.S. patent application Ser. No. 16/654,627,filed Oct. 16, 2019, now U.S. Pat. No. 11,109,854, which is acontinuation of U.S. patent application Ser. No. 14/845,364, filed Sep.4, 2015, now U.S. Pat. No. 10,448,943, which is a continuation of U.S.patent application Ser. No. 14/206,936, filed Mar. 12, 2014, now U.S.Pat. No. 9,168,124, which claims the benefit of U.S. ProvisionalApplication No. 61/782,944, filed Mar. 14, 2013, the disclosures ofwhich are incorporated by reference in their entirety herein.

TECHNICAL FIELD

This disclosure relates to the field of surgery and, more particularly,to suture constructs and methods of enhancing the pull out strength ofsoft tissue grafts.

BACKGROUND

Reconstructive surgeries, particularly tendon or ligamentreconstruction, are well-known in the art. In general, these methodsinvolve repairing a tendon or ligament by stitching it together or usinga graft to repair the tendon or ligament. ACL repairs involve drilling atunnel through the tibia, drilling a closed tunnel (socket) into thefemur, inserting a substitute ACL graft into the tunnels, and securingthe graft to the walls of the tibial and femoral tunnels usinginterference screws or the like. Tensioning and fixation of the graft inthe tunnel is important for optimal results.

Repairs of other tendons or ligaments, such as the Achilles tendon,require trying to reattach the torn pieces of the existing tendon backtogether. This can be difficult to accomplish when the tendon ends areweaker because of the tear. The stitches can rip through the tendon atthe repair site.

Attaching a fixation device such as an ACL TightRope® or button to theend of a tendon is also difficult. The graft is often too short or toothick to be folded over the fixation device. Current techniques mostlyinvolve suturing the tendon and then tying the suture to the button.This type of fixation is dependent on the suture-tendon interface whichcan be too weak for certain indications such as ACL reconstruction. A“rip-stop” suturing technique is disclosed, for example, in USPublication No. 2012/0046746, entitled “Reinforced Biological Constructand Method of Reinforcing Biological Construct,” the disclosure of whichis incorporated in its entirety by reference herein. As detailed in USPublication No. 2012/0046746, the “rip-stop” technique can reinforce thestitching but it is difficult to use with a fixation device.

Accordingly, there is a need for simplified attachment of tendons orligaments to fixation devices using suturing techniques such as the“rip-stop” suturing technique. Also needed are constructs that allowreinforcement of a ligament or tendon attached to a fixation device, aswell as methods of reinforcing a repaired tendon or ligament at therepair site. Also needed are constructs and methods for threading suturethrough a tendon with maximum fixation strength, as well as methods ofsecuring the tendon to bone that allows for accelerated tendon healingto bone.

SUMMARY

A method of reinforcing a biological construct according to an exemplaryaspect of the present disclosure includes, among other things, attachinga suture loop/needle construct to a reinforcement material and stitchingthe reinforcement material to a biological construct to form areinforced biological construct. The reinforcement material is attachedto the suture loop/needle construct prior to approximating thereinforcement material to the biological construct.

In a further non-limiting embodiment of the foregoing method, thesuture/loop needle construct comprises a needle attached to acontinuous, uninterrupted suture loop.

In a further non-limiting embodiment of either of the foregoing methods,the needle is a free floating needle.

In a further non-limiting embodiment of any of the foregoing methods,the reinforcement material is selected from the group consisting of asuture, a tape, a suture tape, a weave, a mesh, and combinationsthereof.

In a further non-limiting embodiment of any of the foregoing methods,the reinforcement material is absorbable.

In a further non-limiting embodiment of any of the foregoing methods, atleast one fixation device is attached to the reinforced biologicalconstruct.

In a further non-limiting embodiment of any of the foregoing methods,the at least one fixation device is a knotless, self-locking, adjustableconstruct formed of a button/loop construct having a button and aflexible, adjustable loop connected to the button, the flexible,adjustable loop having an adjustable length, the flexible, adjustableloop having two ends, two splices and two adjustable independentlyformed loops that are interconnected.

In a further non-limiting embodiment of any of the foregoing methods,stitching the reinforcement material includes whipstitching thereinforcement material to an end of the biological construct.

In a further non-limiting embodiment of any of the foregoing methods,the whipstitching includes passing the suture loop/needle constructthrough the reinforcement material and the end multiple times to createmultiple stitches in the reinforcement material and the end and afterthe last pass of the suture loop/needle construct through the end,passing one limb of a continuous suture loop of the suture loop/needleconstruct through each side of the biological construct.

In a further non-limiting embodiment of any of the foregoing methods,the reinforced biological construct is attached to a suture loop/buttonconstruct.

In a further non-limiting embodiment of any of the foregoing methods,attaching the reinforced biological construct to the suture loop/buttonconstruct includes looping the reinforced biological construct over asuture loop of the suture loop/button construct.

A method of reinforcing a biological construct according to anotherexemplary aspect of the present disclosure includes, among other things,fixedly attaching a suture loop/needle construct to a reinforcementmaterial and after fixedly attaching the suture loop/needle construct tothe reinforcement material, whipstitching the reinforcement material toa graft to form a reinforced graft construct using the sutureloop/needle construct.

In a further non-limiting embodiment of the foregoing methods, thesuture loop/needle construct includes a continuous suture loop.

In a further non-limiting embodiment of either of the foregoing methods,the continuous suture loop is fixedly attached to the reinforcementmaterial.

In a further non-limiting embodiment of any of the foregoing methods,the continuous suture loop of the suture loop/needle construct isswedged to the reinforcement material.

In a further non-limiting embodiment of any of the foregoing methods,the continuous suture loop of the suture loop/needle construct isknotted to the reinforcement material.

In a further non-limiting embodiment of any of the foregoing methods,the method includes clamping the reinforcement material to the graftprior to whipstitching the reinforcement material to the graft.

In a further non-limiting embodiment of any of the foregoing methods,the method includes aligning a distal aspect of the reinforcementmaterial to a distal aspect of the graft prior to whipstitching thereinforcement material to the graft.

In a further non-limiting embodiment of any of the foregoing methods,the method includes connecting the reinforced graft construct to abutton/loop construct.

In a further non-limiting embodiment of any of the foregoing methods,the method includes connecting the reinforcement material to a fixationdevice prior to whipstitching the reinforcement material to the graft.

The embodiments, examples and alternatives of the preceding paragraphs,the claims, or the following description and drawings, including any oftheir various aspects or respective individual features, may be takenindependently or in any combination. Features described in connectionwith one embodiment are applicable to all embodiments, unless suchfeatures are incompatible.

The various features and advantages of this disclosure will becomeapparent to those skilled in the art from the following detaileddescription. The drawings that accompany the detailed description can bebriefly described as follows.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an exemplary reinforcement construct (sutureloop/needle construct with attached reinforcement material) of thepresent disclosure.

FIGS. 2-4 illustrate subsequent steps of a method of preparing areinforced graft with the construct of FIG. 1, and according to anexemplary embodiment of the present disclosure.

FIG. 5 illustrates the reinforced graft construct of FIG. 4 employed inACL reconstruction and according to an exemplary method of the presentdisclosure.

FIGS. 6 and 7 illustrate a top view and a side view, respectively, ofanother exemplary reinforcement construct of the present disclosure.

FIG. 8 illustrates the reinforcement construct of FIG. 7 attached to afixation device (an exemplary ACL TightRope®) and according to anexemplary embodiment of the present disclosure.

FIG. 9 illustrates the assembly of FIG. 8 attached to a tendon, ligamentor graft (by whipstitching) to form a reinforced ligament or tendonconstruct (a top view).

FIG. 10 illustrates the assembly of FIG. 8 attached to tissue (a tendon,ligament or graft) by whipstitching to form a reinforced ligament ortendon construct (a bottom view).

FIGS. 11 and 12 illustrate another exemplary reinforcement construct andassembly of the present disclosure.

FIGS. 13-16 illustrate exemplary steps of a method of attaching thereinforcement construct of FIG. 12 to tissue (tendon, ligament orgraft).

FIG. 17 illustrates another exemplary reinforcement construct andassembly of the present disclosure.

FIGS. 18-22 illustrate exemplary steps of a method of attaching thereinforcement construct of FIG. 17 to tissue (tendon, ligament orgraft).

FIGS. 23-31 illustrate additional exemplary embodiments of reinforcementconstructs and methods of attaching them to tissue (tendon, ligament orgraft).

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present disclosure details surgical constructs and methods fortissue to bone repair employing a tissue construct reinforced with areinforcement (reinforcing) material such as suture, tape, weave ormesh, among many others. The tissue construct may be any biologicalconstruct (for example, graft, ligament or tendon construct) that isemployed for repairing a tendon or ligament, or similar anatomicalstructure. The construct may be attached to any fixation device(s)and/or to any bone tunnel(s).

In an exemplary-only embodiment, the reinforcement construct is in theform of a wide “tape like” material provided, on one end, with a loopthat can be attached to a fixation device (for example, a RetroButton®(U.S. Patent Application Publication No. 2008/0046009), ACL Tightrope®(U.S. Pat. No. 8,460,379) or other suture loop/button construct). Thewide “tape like” area is placed over the tendon or ligament and permitsthe surgeon to include the construct into the tendon/ligament stitches.The “tape like” material may include suture, Fiberwire® (U.S. Pat. No.6,716,234), FiberTape® (U.S. Pat. No. 7,892,256), absorbable suture,tape, weave, or mesh, or any other material or combination of suchmaterials. The “tape like” material is provided on the ligament ortendon, along a length thereon, and whipstitched to provide additionalfixation when the ligament or tendon is implanted. The material may beabsorbable or non-absorbable.

Preferably, the length of the construct approximates the length of thetendon or ligament that would normally be stitched.

In an exemplary embodiment, the construct is attached to a fixationdevice such as an exemplary ACL TightRope® or other button/suture loopconstruct. Attachment may be conducted simultaneously with the formationof the fixation device or may be conducted after the formation of thefixation device (i.e., the construct could be added secondarily to thefixation device).

The reinforced tissue constructs preferably include a stitched regionformed by employing a suture loop construct with (1) a free floatingneedle that is attached to a continuous suture loop, and also with (2) apiece of material attached to the continuous suture loop. As detailedbelow, the piece of material is attached/affixed to at least a portionof the tissue (graft, ligament or tendon) to reinforce the tissue. Thematerial may be any reinforcement (reinforcing) material such as suture,tape, weave, or mesh that can be attached (sutured) to the tissue. In anexemplary-only embodiment, the material is a suture tape such asFiberTape® (U.S. Pat. No. 7,892,256) manufactured by Arthrex, Inc.Naples, Fla., or a collagen tape, or a combination of these materials.The material may be attached to the tissue by suturing (for example,stitching such as whipstitching) or by any other affixing/attachmenttechniques, to provide additional fixation when implanted.

The reinforcing material may be bioabsorbable such that it will resorbaway after a period of time in the body. The reinforced tissue (graft,ligament or tendon) construct may also be formed into a loop with atleast one fixation device attached to the reinforced graft construct forvarious repairs such as ACL repairs. Tissue may be also directlyattached to a fixation device, for example, a TightRope® construct (orother adjustable loops with button constructs) using the reinforcingmaterial and attachment/suturing technique of the present disclosure.

The present disclosure also provides methods of forming reinforcedtissue constructs having increased pull-out strength as well as methodsof securing such reinforced tissue constructs in bone tunnels orsockets. An exemplary method of forming a reinforced tissue construct(reinforced biologic construct) according to the present disclosurecomprises inter alia the steps of: (i) providing one or more tissuestrands; and (ii) suturing/stitching at least a portion of the tissuestrand(s) employing a suture loop/needle construct having a materialattached to the suture loop/needle construct.

Referring now to the drawings, where like elements are designated bylike reference numerals, FIGS. 1-31 illustrate exemplary surgicalconstructs 60, 160, 260, 360 of the present disclosure and methods offorming reinforced tissue constructs 99, 199, 299, 399 with suchsurgical constructs 60, 160, 260, 360.

Surgical construct 60 of FIG. 1 comprises a flexible suture loop/needleconstruct 50 with an attached piece of material 20. The flexible sutureloop/needle construct 50 may be a construct similar to the FiberLoop®construct detailed and disclosed in U.S. Pat. No. 8,298,284 issued onOct. 30, 2012, the disclosure of which is incorporated by referenceherein in its entirety.

As detailed in U.S. Pat. No. 8,298,284, the suture loop/needle construct50 includes a continuous loop of suture 10 (preferably a continuous loopof #2 FiberWire® suture (U.S. Pat. No. 6,716,234), sold by Arthrex, Inc.of Naples, Fla.) with both ends attached to a free floating thin needle11 (such as a thin nitinol needle). The thin needle 11 is preferablystraight and easy to handle, without instruments. The needle 11 movesfreely on the suture loop 10 to recenter itself after passing throughtissue and to facilitate even tensioning. The free floating needle 11 isnot swaged on the suture loop 10 so, after passing the suture loopconstruct through the tissue to be treated, the needle may be recenteredif the suture strands are uneven.

Surgical construct 60 is formed of suture loop/needle construct 50 withmaterial 20 attached to the continuous suture loop 10. Material 20 maybe any reinforcement/reinforcing material that can be attached (sutured)to the tissue (tendon/graft/ligament). In exemplary only embodiments,the material may be suture, tape, weave, or mesh, or any combinations ofthese materials. The material 20 may be suture tape such as FiberTape®(as disclosed in U.S. Pat. No. 7,892,256) or collagen tape, orcombinations thereof. The material 20 may be bioabsorbable such that itwill resorb away after a period of time in the body, or may be providedwith various medicinal or therapeutic agents, for example, antiseptics,antibiotics, drugs, pharmaceutical agents, hormones and growth materials(for example, autogenous growth factors such as platelet-rich plasma(PRP), autologous factors, autologous-conditioned plasma (ACP)), amongmany others).

The material may have any shape and geometry that provides reinforcementto the tissue to be sutured. For example, and according to anexemplary-only embodiment, the material may have a rectangularconfiguration (as shown in FIGS. 1 and 2) with a length of about 22.5mm, or any configuration as long as it provides a surface area on whichsuturing/stitching may be conducted. The material may be provided in anylength/width and then cut depending upon the configuration and geometryof the tissue (graft) to be reinforced.

FIG. 1 illustrates construct 60 with an exemplary 22.5 mm length ofFiberTape® 20 swedged on to the FiberLoop® 10. Material 20 could bestandard suture tape such as FiberTape® or a collagen suture tape. Inaddition, the tape (for example, FiberTape®) could be provided longerand/or wider to allow the surgeon to cut it to the desired length and/orwidth, depending on the area of attachment (suturing or whipstitching).Material 20 may be attached to the continuous suture loop 10 by anymethod known in the art, for example, by swedging or knotting.

FIG. 2 illustrates material 20 disposed over tissue 80 (for example,graft or tendon 80 or any soft tissue). The distal aspect of material 20is aligned with the distal aspect of the graft 80 and held in place witha clamp 40 (for example, an Alice clamp).

FIG. 3 shows secure attachment of the material 20 to the graft 80 by,for example, stitching (for example, whipstitching) the graft bypiercing the material 20 with each step. Details of a method ofstitching with a continuous suture loop with a free floating needleattached to it (such as FiberLoop® system 50) are set forth in U.S. Pat.No. 8,298,284, the entire disclosure of which is incorporated byreference in its entirety herewith.

FIG. 4 illustrates how the FiberLoop® is passed through without havingto double-back to form exemplary reinforced graft construct 99. Afterthe last pass, one limb of the suture is brought back through theFiberTape® such that each suture limb is on either side of the graft.This allows the surgeon to pull the graft in-line with itself. Thisallows for a much stronger construct and much less suture bulk, which inturn, allows for smaller graft tunnels.

FIG. 5 illustrates a schematic view of a knee 90 undergoing ACLreconstruction employing the reinforced graft construct 99 formedaccording to an embodiment of the present disclosure. Graft construct 99is secured within femoral and tibial tunnels (sockets) 91 a, 92 a, eachformed in femur 91 and tibia 92, respectively.

The femoral and tibial tunnels (sockets) 91 a, 92 a may be formed by aknown technique, or alternatively, by using a retrodrill technique.According to the retrodrill technique, the tibial or femoral sockets areprepared by employing a retrodrill device provided with a retrodrillcutter detachable from a retrodrill guide pin, in the manner describedin U.S. Patent No. 7,238)89, issued Jul. 3, 2007, entitled “ACLReconstruction Technique Using Retrodrill,” the entire disclosure ofwhich is incorporated by reference herein in its entirety.

Preferably, the step of securing the reinforced graft construct 99 in atleast the tibial and femoral sockets or tunnels may be accomplished byplugging the target tunnel with a synthetic plug, bone plug or screw tocontain and secure the reinforced graft construct 99 in the tunnel or,alternatively, by employing knotless lateral fixation using, forexample, two knotless fixation devices (such as interference screws orgraft bolt-type fixation devices). The fixation devices may bepreferably formed of a translucent or transparent polymer material,preferably bioabsorbable materials such as polyglycolic or polylacticacid polymers.

According to yet another embodiment, graft insertion and fixation may beconducted by employing a continuous loop/button construct provided witha button, preferably of titanium alloy, and a continuous loop attachedto the button. The button has an oblong configuration and a width thatis preferably less than about 1 mm narrower than the width of the drillhole through which the button is inserted and subsequently passedthrough. The button is provided with an inside eyelet that allows thepassage of the continuous loop. In an exemplary embodiment, the sutureloop may be a single high strength suture such as FiberWire® suture. Inanother exemplary embodiment, the continuous loop may be formed of aplurality of suture strands configured to separate from a single strandto a plurality of strands in a continuous loop. In yet anotherembodiment, the loop is an adjustable loop (forming a TightRope® ACLconstruct) which consists of two interconnected, adjustable flexibleloops formed by splicing a suture strand in a manner disclosed in U.S.Pat. No. 8,439,976 issued on May 14, 2013 and U.S. Pat. No. 8,460,379issued on Jun. 11, 2013, the disclosures of both of which areincorporated by reference in their entireties herein.

When employing an adjustable button/loop construct such as the sutureloop/button construct disclosed in U.S. Pat. Nos. 8,439,976 and8,460,379 (comprising an adjustable loop formed of two interconnectedloops (two eyesplice loops) and two splices), the tissue may be attacheddirectly to the adjustable button/loop construct using the suturingtechnique of the present disclosure (i.e., using surgical construct 60to secure material 20 to tissue while suturing the tissue). The tissueis looped over the adjustable loop of the button/suture loop constructand then secured to it by employing construct 60 with material 20attached to the continuous loop of suture 10. Securing the two ends ofthe tissue to the adjustable loop may be conducted in various ways, forexample, by the methods and techniques disclosed in U.S. Publication No.2012/0046746, the disclosure of which is incorporated herein in itsentirety. The ends of the tissue (graft) to be reinforced may be broughttogether in an overlapping or non-overlapping manner, and then securedand reinforced by suturing/stitching with material 20 to the tissue.

FIGS. 6-10 illustrate a reinforced graft construct for repairing atendon or ligament formed by attaching a piece of material (reinforcingmaterial) having a general rectangular configuration to the graftlengthwise. An end of the material is provided with a loop or an eyeletto permit direct attachment to a fixation device, for example, to asuspensory fixation device such as a suture loop/button construct havinga continuous flexible loop with an adjustable perimeter (for example, anACL TightRope®).

Like in the previously-described embodiment, the material may bebioabsorbable such that it will resorb away after a period of time inthe body. The graft (tendon or ligament) and the material arewhipstitched together as is known in the art to provide for addedstrength of the graft for better fixation.

FIGS. 6 and 7 illustrate an exemplary construct 20 a in the form of awide “tape like” material 20 (reinforcing material 20) provided, on oneend, with a loop 22 that can be attached to a fixation device.Preferably, the length of the construct approximates the length of thetendon/ligament/graft that will be stitched.

FIG. 8 illustrates construct 20 a attached to exemplary fixation device150 in the form of an ACL TightRope® 150, to form assembly 160.Construct 20 a can be provided pre-assembled to the adjustable,continuous, knotless loop of the fixation device 150 (pre-constructedwith the loop 22 attached to the fixation device 150) or the construct20 a could be added secondarily to the fixation device.

The TightRope® ACL construct 150 is an adjustable knotless fixationdevice with a button 55 and two interconnected suture loops 56 formingtwo eyesplices 58, the loops being adjustable and connected to eachother, and further attached to the button. The TightRope® ACL constructoffers adjustable cortical fixation for cruciate ligament reconstruction(as a four-point knotless fixation that resists cyclic displacement andoffers strong pull-out strength).

FIGS. 9 and 10 illustrate assembly 160 attached to tendon/ligament/graft80 to form reinforced graft assembly 200 (including reinforced graftconstruct 199).

The wide “tape like” area 20 (reinforcing material 20) of construct 20 ais placed over the tendon/ligament/graft 80 and permits the surgeon toinclude the construct 20 a into the tendon/ligament stitches 77. The“tape like” material 20 may include suture, FiberWire®, tape such asFiberTape®, absorbable suture, weave, or mesh, or any other material orcombination of such materials that can be provided on the ligament ortendon, along a length thereon, and whipstitched to provide additionalfixation when the ligament or tendon is implanted. The material 20 ofconstruct 20 a may be absorbable or non-absorbable.

Construct 20 a of the present disclosure allows a straight tendon (thatcannot be folded) to be connected to a suspensory fixation device suchas the ACL TightRope®.

In one embodiment, assembly 200 may be used for an arthroscopic repairsuch as ACL repair. A variety of fixation devices for the tibia and/orfemur may be attached to the loop 22 of construct 20 a and for furtherattachment to a graft/ligament/tendon for ACL repair with fixation ateither one or both ends (and prior to the loop formation). Examples offixation devices include a loop with a button (such as the RetroButton®manufactured by Arthrex Inc.) or an adjustable loop with button (such asthe ACL TightRope® manufactured by Arthrex Inc.).

Material 20 (reinforcing material 20) of construct 20 a is stitched tothe graft/ligament/tendon 80 using a needle and suture, for example, towhipstitch through the construct 20 and the graft/ligament/tendon 80, tocreate reinforced assembly 200 (reinforced graft, ligament or tendonloop construct 199 attached to a continuous loop/button sutureconstruct). Once the whipstitching is completed, the reinforced assemblymay be pre-tensioned to 20 pounds for use in ACL repair. The type ofrepair for which the construct is being used for will determine theamount of pre-tensioning, which may be up to 50 pounds.

Although the above method was described using whipstitching, any type ofsuturing/stitching that would attach construct 20 a tograft/ligament/tendon 80 could be used. Additionally, the construct 20 aattached to the graft/ligament/tendon 80 may be an absorbable suturetape that would resorb away after a length of time in the body.

FIGS. 11-16 illustrate another construct and method of reinforcing softtissue graft/ligament/tendon 80 using a FiberLoop® 10 with construct 20.FiberTape® 20 is attached to the FiberLoop® 10 with needle 11 through aplurality of tails/ends 10 a, 10 b, to form construct 260 as shown inFIG. 12. Material 20 could be standard suture tape such as FiberTape® ora collagen suture tape. In addition, the tape (for example, FiberTape®)could be provided longer and/or wider to allow the surgeon to cut it tothe desired length and/or width, depending on the area of attachment(suturing or whipstitching). Material 20 may be formed as part of thecontinuous suture loop 10.

FIG. 13 illustrates material 20 of construct 260 disposed over tissue 80(for example, graft or tendon 80 or any soft tissue) for reinforcedwhipstitch technique. The FiberTape® portion is placed over the graftend to be stitched.

FIGS. 14-16 illustrate securing of material 20 to tissue 80 bystitching, for example, with the flexible strand of loop 10 to formreinforced construct 299 with stitching pattern 77. The graft 80 and theFiberTape® tail 20 are being stitched together with the FiberLoop® (FIG.14). A complete first stitch is shown in FIG. 15 and the final softtissue construct 299 reinforced with material 20 as part of assembly 300(with suturing pattern 77) is shown in FIG. 16.

FIGS. 17-22 illustrate another construct 360 and method of reinforcingsoft tissue graft/ligament/tendon 80 using a longer reinforcementmaterial 20 b which is also part of FiberLoop® 10 through ends/splices10α, 10α, as shown in FIG. 17.

Longer FiberTape® 20 b is folded over the graft 80, as shown in FIG. 18.Exemplary implant 150 (for example, an ACL TightRope® 150) is placed inthe looped FiberTape® 20 b (FIG. 19). A FiberLoop® stitch 77 is thenplaced through the graft 80 and folded FiberTape® 20 b, as shown in FIG.20. Completed reinforced graft construct 399 as part of assembly 400 isillustrated in FIGS. 21 and 22.

FIGS. 23-31 illustrate additional embodiments of constructs 20 c, 20 d,20 e, 20 f, 20 g, 20 h for attachment to a graft/ligament/tendon 80.FIGS. 23-25 illustrates construct 20 c with loop 22 and two suture tapetabs 20 ci, 20 c 2 (FiberTape® tabs) that allow FiberTape® reinforcementon both sides of the graft/ligament/tendon 80. The graft/ligament/tendonis placed between tabs 20 c 1, 20 c 2 and then it is sutured (stitched)to the tabs 20 ci, 20 c 2 with stitches 77.

FIGS. 26 and 27 illustrate a two-ply construct 20 d with circumferentialconnections 13. The connections 13 are provided between the tabs 20 di,20 d 2 to allow the construct 20 d to slide over thegraft/ligament/tendon 80 circumferentially (as shown in FIG. 27).

FIG. 28 illustrates construct 20 e in the form of a length of FiberTape®with a plurality of external eyelets 22 used for suturing. Externaleyelets 22 may be provided in any number and may have any shape (similarand/or different). As shown in FIG. 28, external eyelets 22 are providedalong at least two lengths of the FiberTape® 20, and/or around theperimeter of the FiberTape® 20.

FIG. 29 illustrates construct 20 f in the form of a length of FiberTape®with a plurality of internal eyelets 22′ used for suturing. Internaleyelets 22′ are provided within the body of the FiberTape® 20, atsymmetrical or non-symmetrical positions.

FIGS. 30 and 31 illustrate additional constructs 20 g, 20 h with eyelets22, 22′ and connections 13, and according to other embodiments of thepresent disclosure.

Although some of the embodiments above have been described withreference to attachment of the reinforced tissue to a specificbutton/loop construct (such as an ACL TightRope®, for example), it mustbe understood that the disclosure is not limited to these exemplary-onlyembodiments. Accordingly, the present disclosure also contemplatesattachment of the reinforced tissue (reinforced with material 20 ofsurgical construct 60, 160, 260, 360) to any device (e.g., any type offixation device) or a bone tunnel.

The present disclosure further provides methods of ligamentreconstruction employing reinforced tissue constructs. An exemplarymethod of the present disclosure comprises inter alia the steps of: (i)providing a target tunnel for ligament reconstruction; (ii) providing astitched reinforced tissue construct comprising at least a reinforcedstitched region, the reinforced stitched region including areinforcement (reinforcing) material located between tissue(tendon/ligament/graft) and the stitching; (iii) inserting the stitchedtissue construct into the target tunnel; and (iv) securing the stitchedtissue construct in the tunnel.

Reinforcement material 20 may consist essentially of suture or suturematerial, or of combination of suture and other materials such as longchain synthetic polymers like polyester and nylon, or materials such asPET, silk nylon or absorbable polymers, or coating materials (such aswax, silk, or silicone products), among many others. These materialsaugment the strength and pliability of the construct, and improve thecharacteristics and properties of the suture material.

The suture forming the continuous loop 10 attached to material 20 may beformed of any flexible material. In the preferred embodiment, thesutures are formed of a high strength suture material such as FiberWire®suture, sold by Arthrex, Inc. of Naples, Fla., and described in U.S.Pat. No. 6,716,234, the disclosure of which is incorporated by referenceherein. The high strength suture may be available in various lengthsand, preferably, is a #2 FiberWire® suture strand. FiberWire® suture isformed of an advanced, high-strength fiber material, namely ultrahighmolecular weight polyethylene (UHMWPE), sold under the tradenamesSpectra (Honeywell) and Dyneema (DSM), braided with at least one otherfiber, natural or synthetic, to form lengths of suture material.

While the present embodiments are described herein with reference toillustrative figures for particular applications, it should beunderstood that the embodiments are not limited thereto. Those havingordinary skill in the art and access to the teachings provided herein,will recognize additional modifications, applications, embodiments andsubstitution of equivalents all falling within the scope of thepresented embodiments.

What is claimed is:
 1. A method of reinforcing a biological construct,comprising: attaching a suture/needle construct to a reinforcementmaterial; and whipstitching the reinforcement material to a biologicalconstruct to form a reinforced biological construct, wherein thewhipstitching includes: passing the suture/needle construct through thereinforcement material and the biological construct multiple times tocreate multiple stitches in the reinforcement material and thebiological construct, wherein a suture loop/button construct is attachedto the reinforced biological construct.
 2. The method as recite in claim1, wherein the suture/needle construct comprises a needle attached to acontinuous, uninterrupted suture loop.
 3. The method as recited in claim2, wherein the needle is a free floating needle.
 4. The method asrecited in claim 1, wherein the reinforcement material is selected fromthe group consisting of a suture, a tape, a suture tape, a weave, amesh, and combinations thereof.
 5. The method as recited in claim 4,wherein the reinforcement material is absorbable.
 6. The method asrecited in claim 1, wherein the suture loop/button construct is aknotless, self-locking, adjustable construct having a button and aflexible, adjustable loop connected to the button, the flexible,adjustable loop having an adjustable length, the flexible, adjustableloop having two ends, two splices and two adjustable independentlyformed loops that are interconnected.
 7. The method as recited in claim1, wherein the reinforcement material is attached to the suture/needleconstruct prior to approximating the reinforcement material to thebiological construct.
 8. The method as recited in claim 1, wherein thereinforced biological construct is looped over a suture loop of thesuture loop/button construct.
 9. The method as recited in claim 1,wherein the biological construct is a graft.
 10. The method as recitedin claim 9, wherein the suture/needle construct includes a continuoussuture loop.
 11. The method as recited in claim 10, wherein thecontinuous suture loop is fixedly attached to the reinforcementmaterial.
 12. The method as recited in claim 11, wherein the continuoussuture loop of the suture/needle construct is knotted or swedged to thereinforcement material.
 13. The method as recited in claim 9, comprisingclamping the reinforcement material to the graft prior to whipstitchingthe reinforcement material to the graft.
 14. The method as recited inclaim 9, comprising aligning a distal aspect of the reinforcementmaterial to a distal aspect of the graft prior to whipstitching thereinforcement material to the graft.
 15. The method as recited in claim9, comprising connecting the reinforced biological construct to thesuture loop/button construct.
 16. The method as recited in claim 9,comprising connecting the reinforcement material to the sutureloop/button construct prior to whipstitching the reinforcement materialto the graft.
 17. The method as recited in claim 1, wherein the whipstitching includes: inserting the suture/needle construct through aproximal end of the reinforcement material and through the biologicalconstruct to create a first whipstitched region; and inserting thesuture/needle construct through the reinforcement material and throughthe biological construct to create a second whipstitched region that isdistal to the first whipstitched region.
 18. The method as recited inclaim 17, wherein a needle of the suture/needle construct is passedthrough a first side of the reinforcement material prior to passingthrough a second side of the reinforcement material when creating boththe first and second whipstitched regions.
 19. The method as recited inclaim 1, wherein a button of the suture loop/button construct is anon-flexible component.
 20. The method as recited in claim 18, whereinthe button is a metallic button.